FDA 510(k) Applications Submitted by NuVasive, Incorporated

FDA 510(k) Number Submission Date Device Name Applicant
K170271 01/27/2017 NuVasive(r) Monolith Corpectomy System NuVasive, Incorporated
K150474 02/23/2015 NuVasive VuePoint II OCT System NuVasive, Incorporated
K140479 02/26/2014 COROENT XL-F SYSTEM NUVASIVE, INCORPORATED
K170592 02/28/2017 NuVasive BASE Interfixated Titanium System NuVasive, Incorporated
K170961 03/31/2017 NuVasive CoRoent Small Interlock II System NuVasive, Incorporated
K140921 04/10/2014 COROENT SMALL INTERBODY SYSTEM NUVASIVE, INCORPORATED
K150994 04/15/2015 NuVasive CoRoent Thoracolumbar Implants NUVASIVE, INCORPORATED
K161265 05/05/2016 NuVasive« VersaTie System NUVASIVE, INCORPORATED
K151214 05/06/2015 ALIF Interfixated System NuVasive, Incorporated
K171633 06/02/2017 NuVasive TLX Interbody System NuVasive, Incorporated
K172123 07/14/2017 NuVasive« Modulus XLIF Interbody System NuVasive, Incorporated
K172341 08/02/2017 NuVasive« Modulus TLIF Interbody System NuVasive, Incorporated
K142299 08/18/2014 CoRoent Small Interlock System NUVASIVE, INCORPORATED
K122910 09/21/2012 ARCHON ANTERIOR CERVICAL PLATE SYSTE, NUVASIVE, INCORPORATED
K173025 09/28/2017 NuVasive« MLX« û Medial Lateral Expandable Lumbar Interbody System; NuVasive« AP Expandable XLIF System NuVasive, Incorporated
K143595 12/18/2014 NuVasive(R) CCX-L Interbody System NuVasive, Incorporated
K173892 12/21/2017 NuVasive« XLX Interbody System NuVasive, Incorporated
K163707 12/29/2016 NuVasive CoRoent Ti-C System NuVasive, Incorporated
K112709 09/19/2011 STIMULATION/DISSECTION INSTRUMENTS NUVASIVE, INCORPORATED
K190636 03/12/2019 NuVasive« Reline« 4.5-5.0 System NuVasive, Incorporated
K140563 03/05/2014 LATERAL VBR SYSTEM NUVASIVE, INCORPORATED
K130820 03/25/2013 EXPANDABLE LUMBAR INTERBODY SYSTEM NUVASIVE, INCORPORATED
K133530 11/15/2013 NUVASIVE EMG ENDOTRACHEAL TUBE NUVASIVE, INCORPORATED
K143641 12/22/2014 NuVasive NVM5 System NuVasive, Incorporated
K192760 09/30/2019 NuVasive Modulus XLIF Interbody System NuVasive, Incorporated
K181386 05/25/2018 NuVasive Brigade Lateral System NuVasive, Incorporated
K191500 06/06/2019 NuVasive« ACP System NuVasive, Incorporated
K190418 02/21/2019 NuVasive« VersaTie« System NuVasive, Incorporated
K182974 10/26/2018 NuVasive Reline System NuVasive, Incorporated
K153336 11/19/2015 VuePoint OCT System NUVASIVE, INCORPORATED
K192435 09/05/2019 NuVasive NuvaLine NuVasive, Incorporated
K170800 03/17/2017 NuVasive LessRay with Enhanced Tracking NuVasive, Incorporated
K172623 09/01/2017 NuVasive Navigation Instruments NuVasive, Incorporated
K173314 10/19/2017 LessRay System NuVasive, Incorporated
K150362 02/12/2015 NuVasive CoRoent Small Interbody System NuVasive, Incorporated
K180498 02/26/2018 NuVasive Reline Fenestrated Screws, High V+ Bone Cement NuVasive, Incorporated
K180550 03/01/2018 NuVasive Monolith Cervical Corpectomy System NuVasive, Incorporated
K161230 05/02/2016 NuVasive Lumbar Interbody Implants NUVASIVE, INCORPORATED
K163491 12/12/2016 NuVasive CoRoent Small Interbody System NuVasive, Incorporated
K153782 12/31/2015 NuVasive« Lumbar Interbody Implants NUVASIVE, INCORPORATED
K151472 06/01/2015 NuVasive CoRoent Lumbar System NuVasive, Incorporated
K171894 06/26/2017 NuVasive« PreceptÖ Spinal System NuVasive, Incorporated
K170962 03/31/2017 NuVasive« CoRoent« Thoracolumbar System NuVasive, Incorporated
K172497 08/18/2017 NuVasive AttraX Scaffold NuVasive, Incorporated
K172676 09/05/2017 NuVasive« Modulus-C Interbody System NuVasive, Incorporated
K160051 01/11/2016 NuVasive« Interfixated Interbody System NuVasive, Incorporated
K180198 01/24/2018 NuVasive« VuePoint« II OCT System NuVasive, Incorporated
K160916 04/01/2016 CoRoent« Ti-C System NUVASIVE, INCORPORATED
K191553 06/12/2019 NuVaisve« Reline« Cervical System NuVasive, Incorporated
K142050 07/28/2014 NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM NUVASIVE, INCORPORATED
K162138 08/01/2016 NuVasive CoRoent Small Ti-C System NUVASIVE, INCORPORATED
K173030 09/28/2017 Vertera Spine Cohere Cervical Interbody Fusion Device NuVasive, Incorporated
K173153 09/29/2017 Vertera SpineÖ CoalesceÖ Thoracolumbar Interbody Fusion System NuVasive, Incorporated
K143065 10/24/2014 NuVasive ALIF Buttress Plate System NUVASIVE, INCORPORATED
K153419 11/25/2015 NuVasive CoRoent Thoracolumbar System NUVASIVE, INCORPORATED
K180038 01/05/2018 NuVasive Pulse System NuVasive, Incorporated
K170126 01/13/2017 NuVasive« Reline« 4.5-5.0 System NUVASIVE, INCORPORATED
K140659 03/14/2014 COROENT THORACOLUMBAR IMPLANTS NUVASIVE, INCORPORATED
K140770 03/27/2014 MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM NUVASIVE, INCORPORATED
K160989 04/08/2016 NuVasive« Reline« System NuVasive, Incorporated
K151167 05/01/2015 NuVasive PEEK Corpectomy System NUVASIVE, INCORPORATED
K151374 05/22/2015 NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System NuVasive, Incorporated
K151538 06/08/2015 NuVasive PEEK Corpectomy Railed System NuVasive, Incorporated
K151651 06/18/2015 NuVasive X-CORE Mini Cervical Expandable VBR System NUVASIVE, INCORPORATED
K181860 07/12/2018 NuVasive Cohere Thoracolumbar Interbody System NuVasive, Incorporated
K141896 07/14/2014 COROENT SYSTEM NUVASIVE, INCORPORATED
K132411 08/02/2013 AFFIX II SPINOUS PROCESS PLATE SYSTEM NUVASIVE, INCORPORATED
K132601 08/20/2013 COROENT STERILE IMPLANTS SYSTEM NUVASIVE, INCORPORATED
K142499 09/05/2014 Reline System NUVASIVE, INCORPORATED
K162647 09/22/2016 NuVasive NuvaLine Mobile App NUVASIVE, INCORPORATED
K142737 09/23/2014 MAS PLIF Fixation system NUVASIVE, INCORPORATED
K172979 09/27/2017 NuVasive« Growth Rod Conversion Set NuVasive, Incorporated
K153105 10/27/2015 MLXÖ - Medial Lateral Expandable Lumbar Interbody System NuVasive, Incorporated
K143388 11/26/2014 Affix IIS Spinous Process Plate System NuVasive, Incorporated
K143579 12/18/2014 NuVasive Sterilization Trays NuVasive, Incorporated
K132694 08/29/2013 NUVASIVE NVM5 SYSTEM NUVASIVE, INCORPORATED
K161014 04/11/2016 NuVasive« Reline« System NUVASIVE, INCORPORATED
K191169 05/01/2019 NuVasive« Camber Laminoplasty System NuVasive, Incorporated


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